Impact of pantoprazole on absorption and disposition of hydroxychloroquine, a drug used in Covid-19
- Conditions
- healthy volunteers
- Registration Number
- DRKS00021573
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
1. Age 18-60 y inclusive at the time of consent,
2. Males and females of child-bearing potential who are willing to use a highly effective method of contraception during the treatment and for 3 months after last administration of the IMP or women not of child-bearing potential (WNCBP) or individuals who are convincingly sexually abstinent.
3. Understanding, ability, and willingness to fully comply with trial interventions and restrictions,
4. Willingness to participate in a genotyping study (K093), and
5. Ability to provide written, personally signed and dated informed consent to participate in the trial, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6, and applicable regulations, prior to any trial-related interventions.
1. Clinically significant or relevant abnormalities in the medical history, physical examination, and laboratory evaluation as assessed by the investigator,
2. Any medical disorder that may require treatment or make the participant unlikely to fully complete the trial, or any condition that presents undue risk from the IMPs or trial interventions,
3. Clinically relevant ongoing or clinically relevant history of physical or psychiatric illness as judged by the investigator,
4. Pregnancy or breast feeding,
5. Any acute or chronic illness or clinically relevant finding known or expected to modify absorption, distribution, metabolism, or excretion of HCQ, midazolam, yohimbine, or pantoprazole,
6. Any known history of severe allergic or anaphylactic reactions to drugs or food or any other clinically significant allergies (except mild forms of hay fever),
7. Any known allergies to the compound or further ingredients of HCQ, quinine, pantoprazole, midazolam, or yohimbine preparations,
8. Prolonged QTc time: women: QTcF > 460 ms, men: QTcF > 440 MS
9. Clinically relevant findings at SCR. Minor deviations of laboratory values from the normal range can be acceptable, if judged by the investigator to be of no clinical relevance for this Trial
10. A positive human immunodeficiency virus and hepatitis C antibody screen,
11. A positive result in the drug screening test
12. Any intake of HCQ, chloroquine or travel to malaria risk regions within the last 3 months,
13. Use of any medication (prescription medication, non-prescription medication including multivitamin or herbal preparations) with active ingredients except hormonal contraception and thyroid hormones, or any intake of substances known to induce or inhibit HCQ-metabolizing enzymes or drug transporters within a period of less than 5 times the respective elimination half-life (t1/2) with regard to the expected date of the first dose of IMP,
14. Consumption of citrus fruits or products of these fruits within 7 d prior to the expected date of first dose of IMP and expected nonadherence to refrain from such products until V5,
15. Expected nonadherence to refrain from alcohol 24 h prior to V1 until V5 of this trial, or excessive alcohol consumption.
16. Intake of quinine, or consumption of quinine-containing drinks (bitter lemon, tonic water, bitter orange)
17. Use of an IMP within 30 d prior to the expected date of receiving the first dose of IMP or active enrolment in another drug or vaccine clinical trial.
18. Contraindications to HCQ use
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the effect of the proton-pump Inhibitor (PPI) pantoprazole on the absorption of HCQ in healthy volunteers
- Secondary Outcome Measures
Name Time Method Comparison of HCQ concentrations in whole blood as compared to plasma and intracellular concentration in PBMCs and evaluation of HCQ as a perpetrator drug in DDI at the Level of cytochrome P450 CYP3A and CYP2D6